Chen Wutao, Zhang Nan, He Zhihong, Li Qing, Wang You, Lou Weihua, Di Wen
Shanghai Key Laboratory of Gynecologic Oncology, School of Medicine, Renji Hospital Shanghai Jiaotong University Shanghai China.
Department of Obstetrics and Gynecology, School of Medicine, Renji Hospital Shanghai Jiaotong University Shanghai China.
Health Sci Rep. 2024 May 2;7(5):e2069. doi: 10.1002/hsr2.2069. eCollection 2024 May.
The effectiveness of immune checkpoint inhibitors (ICIs) in low programmed death ligand 1 (PD-L1) expression in cervical cancer (CC) patients remains unknown. We aimed to evaluate the efficacy of ICIs in low PD-L1 expression CC patients.
The study is an individual patient data (IPD)-based meta-analysis. IPD were compiled through KMSubtraction and IPDfromKM methodologies from high-quality randomized clinical trials and single-arm studies which reported overall survival (OS) or progression-free survival (PFS) stratified by PD-L1 expression. Kaplan-Meier curves and Cox regression analysis were employed to evaluate the survival benefits of ICIs.
A total of eight studies and 1110 cases were included in the analysis. Within the low PD-L1 expression subgroup, ICI combination therapy, but not ICI monotherapy, demonstrated significant OS benefits over non-ICI treatment (hazard ratio [HR] = 0.61, 95% confidence interval [CI]: 0.36-1.04, = 0.06). Concerning PFS, ICI monotherapy was associated with a negative effect compared to non-ICI treatment (HR = 4.59, 95% CI: 2.32-9.07, < 0.001). Notably, both OS and PFS outcomes were unfavorable for ICI monotherapy compared to both non-ICI and ICI combination therapy in the combined positive score <1 subgroup (OS: HR = 2.60, 95% CI: 1.31-5.16, = 0.008; PFS: HR = 7.59, 95% CI: 3.53-16.31, < 0.001).
In patients with CC and low PD-L1 expression, ICI monotherapy may not be considered as the optimal treatment strategy when compared to non-ICI treatment or ICI combination therapy.
CRD42023395103.
免疫检查点抑制剂（ICI）在宫颈癌（CC）患者低程序性死亡配体1（PD-L1）表达中的有效性尚不清楚。我们旨在评估ICI在低PD-L1表达CC患者中的疗效。
本研究是一项基于个体患者数据（IPD）的荟萃分析。通过KMSubtraction和IPDfromKM方法，从高质量随机临床试验和单臂研究中收集IPD，这些研究报告了按PD-L1表达分层的总生存期（OS）或无进展生存期（PFS）。采用Kaplan-Meier曲线和Cox回归分析评估ICI的生存获益。
分析共纳入8项研究和1110例病例。在低PD-L1表达亚组中，ICI联合治疗而非ICI单药治疗，与非ICI治疗相比显示出显著的OS获益（风险比[HR]=0.61，95%置信区间[CI]：0.36-1.04，P=0.06）。关于PFS，与非ICI治疗相比，ICI单药治疗具有负面影响（HR=4.59，95%CI：2.32-9.07，P<0.001）。值得注意的是，在联合阳性评分<1亚组中，与非ICI和ICI联合治疗相比，ICI单药治疗的OS和PFS结果均不理想（OS：HR=2.60，95%CI：1.31-5.16，P=0.008；PFS：HR=7.59，95%CI：3.53-16.31，P<0.001）。
在CC和低PD-L1表达患者中，与非ICI治疗或ICI联合治疗相比，ICI单药治疗可能不被视为最佳治疗策略。
CRD42023395103。
